Within a year of Lombard Medical’s Aorfix regulatory approval in Japan, physicians have completed approximately 400 cases–an estimated 5% of all abdominal aortic aneurysm (AAA) cases in Japan.
Aorfix received approval from the Japanese Ministry of Health, Labour and Welfare in August 2014, and is the first and only endovascular stent graft with worldwide regulatory approvals for the treatment of patients with aortic neck angulations up to 90 degrees.
Lombard chief executive officer Simon Hubbert commented, “The adoption of Aorfix by the vascular surgery community in Japan has been extremely encouraging, as has been the outstanding commercial execution displayed by our distribution partners at Medico’s Hirata. We look forward to the continued adoption of Aorfix in this important and growing market as well as other global markets.”
Japan is the world’s second largest standalone endovascular aortic repair (EVAR) market, estimated at US$140m or 10% of the global market in 2013 and has been growing at an average rate of 18% over the last five years. There are approximately 400 physicians at 200 clinics performing EVAR in Japan, and it is estimated that around 55% of Japanese AAA patients are treated using this minimally invasive method.